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Completed

NCT Number: NCT02119221

Copanlisib Mass Balance Study

The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.

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Key information

Conditions

Healthy Volunteers

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subject
  • Age: 45 to 65 years
  • Body weight greater or equal to 60 kg and body mass index (BMI): above/equal 18 and below/equal 30 kg/m²

Exclusion criteria

  • Regular use of medicines
  • Known recent (last 2 years) abuse of recreational drugs, suspicion of drug or alcohol abuse, or positive results of the drug and alcohol screen tests at screening or baseline
  • Use of strong inhibitors of cytochrome P450 (CYP)3A4, as well as use of St John's Wort or strong inducers of CYP3A4 prohibited from 14 days before the administration of study drug until discharge from the clinic
  • Smoking
  • Average intake of more than 24 units of alcohol per week; Regular daily consumption of more than 1 L of methylxanthine-containing beverages
  • Any condition, which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 2 days) constipation or symptomatic prostatic hypertrophy.
  • Participation in another mass balance study with a radiation burden > 0.1 mSv in the period of 1 year before screening

Treatment and study plan

Copanlisib (BAY80-6946)

Drug

Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of [14C]

Primary outcomes

  1. Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax)

    Time frame: Multiple time points up to 336 hours

  2. Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve from the first time point (t=0) extrapolated to infinity (AUC)

    Time frame: Multiple time points up to 336 hours

  3. Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve to the last data point above the lower limit of quantitation (AUC(0-tlast))

    Time frame: Multiple time points up to 336 hours

  4. Pharmacokinetics of total radioactivity in plasma by Cmax

    Time frame: Multiple time points up to 336 hours

  5. Pharmacokinetics of total radioactivity in plasma by AUC

    Time frame: Multiple time points up to 336 hours

  6. Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast)

    Time frame: Multiple time points up to 336 hours

  7. Pharmacokinetics of total radioactivity in whole blood by Cmax

    Time frame: Multiple time points up to 336 hours

  8. Pharmacokinetics of total radioactivity in whole blood by AUC

    Time frame: Multiple time points up to 336 hours

  9. Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast)

    Time frame: Multiple time points up to 336 hours

  10. Radioactivity excreted in urine as a percentage of the dose (AE,ur)

    Time frame: Multiple time points up to 336 hours

  11. Radioactivity excreted in feces as a percentage of the dose (AE,fec)

    Time frame: Multiple time points up to 336 hours

  12. Metabolite profile in plasma

    Time frame: Multiple time points up to 336 hours

  13. Metabolite profile in urine

    Time frame: Multiple time points up to 336 hours

  14. Metabolite profile in feces

    Time frame: Multiple time points up to 336 hours

Secondary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Until 30 days after study drug administration

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics After Single Intravenous Administration of 12 mg [14C]Copanlisib (BAY 80-6946) in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2014
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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